• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Dr. Obama is in the house

Dr. Obama is in the house

April 22, 2009 By Katie Quackenbush

Suzanne Ryan has a bum knee. If she doesn’t spend most of the day sitting down, she ends up coping with a lot of pain.

Her doctors say there are two options for the semi-retired elementary school teacher: Knee replacement surgery, using state-of-the-art plastic implants, or periodic injections to reduce inflammation and pain and improve joint flexibility.

When MassDevice first speaks with Ryan, in March, she’s unsure which offers the best chance of regaining mobility.

“I’m not sure which treatment I’ll choose,” Ryan says. “The device or the drugs.”

President Barack Obama wants to help her decide.

Comparative effectiveness research — studies to evaluate the relative efficacy medical treatments — is set for a major shot in the arm, with $1.1 billion set aside in the Obama administration’s recently approved American Recovery and Reinvestment Act.

The goal is to improve the quality of healthcare and, not incidentally, reduce the nation’s healthcare spend and its consequent strain on the U.S. economy: More than $2.2 trillion per year, or $7,421 per person, according to the Congressional Budget Office.

Not everyone sees the push for comparative effectiveness as a good thing.

Patient advocacy groups fear that the treatments deemed most effective — read “cheapest” — will be prescribed for every patient, regardless of their individual needs. Hospitals and patients alike are apprehensive about the adoption of low insurance reimbursement rates based on the findings.

And the medical device industry has quite a bit at stake as well: Devices often cost more than other treatments, or serve small, even marginal patient populations.

Industry advocates are all for determining the effectiveness of devices and other therapies, but have reservations about a system that rations care, says Wanda Moebius, vice president of policy communications for the Advanced Medical Technology Assn. (AdvaMed) in Washington, D.C.

“[The fear is that] it’s not about determining what works best,” Moebius says. “It’s about what happens when one treatment is better but costs more.”

Effective or cost-effective?

Medical devices are everywhere: More than 4 percent of Americans have at least one implanted medical device, and devices are used almost every time a patient is treated at a hospital.

That ubiquity, and the potential disparity in their effectiveness versus each other and treatments in other disciplines, has device makers casting a wary eye on the prospect of a nationwide comparative effectiveness blitz.

“How does the system handle a situation where a treatment works 30 percent better than the others, but costs 60 percent more?” Moebius asks.

The fear is that research outcomes will be linked to practice guidelines, meaning care prescribed based on the cost of a given treatment.

Executives at Covidien, the global medical devices giant headquartered in Mansfield, walk a cautious line when asked about their fears and hopes for the initiative.

“Most advocates of comparative effectiveness policies are focused on the patient first and believe that decisions should not be driven by cost,” writes Covidien vice president of global healthcare economics, policy and reimbursement Liesl Cooper in an email. “The focus should be clinical effectiveness, not cost effectiveness. … We share the industry’s support for clinical research. At the same time, we are mindful of the need for patients to have the best care possible.”

“I completely understand why a device industry executive would be concerned about cost effectiveness research,” says Dr. William Maisel, a cardiologist at Boston’s Beth Israel Deaconess Medical Center and founder and director of the Medical Device Safety Institute. “They don’t want cost to be a component of the decision regarding whether or not people use their device.”

But some product lines could benefit if, for example, research indicates they are more effective than medications, Maisel explains. It’s not difficult to imagine a boost in sales for a device placed on an “effective” list.

“If you have a good device that really helps people, you have a great chance of seeing an increase in sales,” Maisel says.

Conversely, for devices of marginal benefit there’s a good chance the research will result in a decline in sales.

“But that’s OK,” he says. “That’s what should happen.”

The British example

Several years ago, the U.K.’s National Health Service launched a comparative effectiveness board that links cost effectiveness with clinical effectiveness. The National Institute for Clinical Excellence combines economic evaluation and quality-adjusted “life year thresholds” to determine whether the cost of a given medical intervention can be justified — and paid for — by the government.

In other words, if the agency doesn’t think the number of quality years added to a patient’s life by a device or therapy are worth the cost, the United Kingdom won’t pay for it.

Scott Atlas, a senior fellow at the conservative Hoover Institution and a professor at Stanford University Medical Center, outlined the results of this policy in a February 2009 report to the National Center for Policy Analysis. 10 Surprising Facts about American Health Care (PDF) reveals several less-than satisfactory aspects of the health service — for example, breast cancer mortality in the U.K. is 88 percent higher than in the United States.

While the U.S. is far from nationalizing healthcare, there is great concern that the government will allow insurance providers to tie reimbursement rates to comparative effectiveness research outcomes.

According to Fran Miller, a professor of law, public health and healthcare management at Boston University and an expert in comparative health systems, patient advocacy groups are worried that government bean counters will bar idiosyncratic patients from access to the devices they need.

“People are worried that the idiosyncratic patient who doesn’t fit the norm will be closed out of the care they should have,” Miller says. “But that doesn’t go down well in our society — the minute a particular patient thinks they’re not getting a device they ‘need,’ people are going to be very upset.”

But Miller and Maisel agree that British-style rationing of care in the U.S. is very unlikely to occur, even in the face of a worsening economy.

“The medical community drives care in the direction of beneficial treatment,” Maisel says. “There is an unrealistic expectation of Americans in general that they are entitled to every therapy, regardless of how expensive it is,” he adds. “That just isn’t realistic. It wasn’t realistic before the economic downturn, and it isn’t now.”

“The bottom line is we can’t keep spending all this money on healthcare when the economy is tanking,” Miller adds.

Upsides and downsides

Comparative effectiveness research has been around for decades, but it’s never received so hearty a boost and so much public attention. On a smaller scale, it’s produced results for institutions and governments. Take Washington state, which used comparative effectiveness research to pare its annual Medicaid prescription drug bill by $40 million.

While the impact on the Massachusetts medical device industry remains to be seen, comparative effectiveness studies and clinical trials often compare device-based therapies with other treatments.

A study comparing several companies’ drug-eluting stents with drug therapy or other surgical interventions, for example, would be a high-stakes competition involving one of the Bay State’s most prominent medical technologies.

“This is life or death for a company,” Miller notes. “If yours isn’t on the list of approved medical devices — goodbye. Nobody goes out and buys devices out of pocket money.”

Although it could prove to be the death knell for some firms, the research might benefit the industry as a whole, indicating which devices invest in and develop.

Ultimately, however, the bottom line is improving healthcare outcomes. Rigorous and fair comparative effectiveness research improves the health of patients, by producing reliable data to improve clinical decision-making.

“I think there is an opportunity to improve patient care and improve patient cost. That’s why I think the stimulus bill is so important,” Maisel says, adding that research results could begin to emerge within 18 to 36 months.

“The device product life cycle is very short and I think, with the research money getting out there very quickly, we could see studies develop very soon,” he says.

Suzanne Ryan isn’t about to wait around for Obama’s initiative to determine which treatment will be best for her. She’s embarked on her own, miniature comparative effectiveness study.

Her doctors, believing she favored her bad knee to the point that her other knee started acting up, are taking a “watchful waiting” approach with more healthy knee, treating it with painkillers and keeping a close eye on its progress.

And she’s scheduled for replacement surgery on the bum knee later this month.

After that, she’ll be a walking example of comparative effectiveness research, able to evaluate each treatment’s effectiveness herself.

Filed Under: Uncategorized

In case you missed it

  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
  • Teva appoints former Vertex exec as new head of R&D, CMO
  • Enovis partners with Kelvi on hot and cold therapies
  • West Pharmaceutical Services debuts new needle syringe system
  • Titan Medical names Cary G. Vance as new president, CEO
  • Acutus completes first closing in left-heart access portfolio sale to Medtronic
  • FDA clears Intuitive, Siemens Healthineers imaging integration for robotic bronchoscopy
  • FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall
  • How safe is health information after the overturning of Roe?
  • Smith+Nephew opens new plant in Malaysia
  • BD launches combination COVID-19, flu, RSV diagnostic test
  • Zimmer Biomet creates independent nonprofit organization to reduce health disparities
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
  • Nasdaq grants Titan Medical 180-day extension to regain compliance
  • Aerin Medical reports positive 4-year results for VivAer treatment
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
  • How medical device companies are responding to abortion bans

RSS From Medical Design & Outsourcing

  • Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future
    All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers. EVP of Global Operations and Supply Chain Greg Smith anticipates fewer suppliers in Medtronic’s future, he said in an interview this week. Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published… […]
  • CeQur is launching a discreet, convenient ‘wearable insulin pen’
    CeQur designed its Simplicity device to make insulin delivery as seamless as possible for people with diabetes. When it comes to managing diabetes, CeQur wants to make insulin therapy as convenient as possible. For those who prefer to manage their own insulin delivery, the Simplicity device might just do exactly that. Simplicity, a wearable, disposable… […]
  • Meddux opens new facility in Colorado
    Engineering, design, development and manufacturing company Meddux announced that it opened a new facility in Boulder, Colorado. The new, 22,000-square-foot facility doubles the overall square footage from its previous location in Colorado. According to a news release, it helps the company to quadruple its product development area and double its manufacturing footprint. Meddux’s new facility… […]
  • Reducing the Overall Cost of Validation
    By PTI Engineered Plastics Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification… […]
  • BBS Automation has a deal to buy medtech supplier Kahle Automation
    BBS Automation said it plans to purchase high-speed automation supplier Kahle Automation to expand its medtech and life sciences business. Kahle will operate as Kahle – a BBS Company, according to a news release from Munich, Germany-based BBS and Lombardy, Italy-based Kahle. The deal is subject to regulatory approval. Terms were not disclosed. Kahle’s co-owners —… […]
  • How safe is health information after the overturning of Roe?
    The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade. Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge… […]
  • Dexcom focuses on early diabetes diagnosis as COVID links emerge
    New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s… […]
  • Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
    Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home. A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year. Salt… […]
  • How medical device companies are responding to abortion bans
    Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access. Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately. Some medtech companies are not using… […]
  • Philips updates on testing results for recalled ventilators
    Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after its… […]
  • ResMed names Lucile Blaise as new Sleep & Respiratory Care leader
    Lucile Blaise will be the new president of ResMed’s Sleep & Respiratory Care business starting July 1, ResMed (NYSE: RMD) said today. She replaces Jim Hollingshead, who became president and CEO of Insulet (Nasdaq:PODD) on June 1. ResMed President and COO Rob Douglas is serving as interim president of the Sleep & Respiratory Care during… […]

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

DeviceTalks Weekly

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS